The currently available methods to treat heart failure are numerous. However they present less hope to survival and quality of life than expected. Among the newest tools in fighting heart failure there stands stem cell therapy. Stem Cell Therapy aims at the rejuvenation of the inactive weak cardiac muscle cells through the introduction of stem cells which are capable of homing, resynthesis of and replacing myocardial cells. Stem cell therapy has proved limited success with concerns about the safety and prognosis.
Another relatively recent method is cardiac resynchronisation therapy ‘CRT’. This entails the introduction of a third lead in a position behind the left ventricle where it can be paced. Through this timed event, the intraventricular as well as the interventricular dyssynchrony may be corrected. This mode of treatment has proved effective in increasing the 6-min walk test and patient symptoms and signs. CRT still poses questionable results and benefits. Also choosing the candidate with potential future success has many limitations as well.
Cardiac transplantation is a more solid treatment option of adding somebody's heart to replace another heart, a human heart from a dead donor to a heart failure recipient. There are a wealth of difficulties to the donor and recipient. Difficulties to the donor include a rarity of donor's hearts which is <3000/year worldwide, heart preservation, transportation, laboratory tests, intrinsic heart disease, ABO blood type compatibility, Donor-Recipient size disparity, transmissible diseases, a 2-5 fold mortality risk to recipient with higher donor age, coronary artery disease, allograft rejection, allograft vasculopathy, and transplanted organ rejection (4%/year).
Difficulties to the recipient include immunosuppressive and cytotoxic medications that lead to malignancy and multi system organ failure, right ventricular (RV) failure, and absence of chronotropic response with the dennervated transplanted heart.
Most patients awaiting a heart transplant are awarded a pretransplant procedure; a ventricular assist device ‘VAD’. They are either short-term, or long-term, i) Pulsatile; or ii) Non-Pulsatile.
They are temporarily placed and lasting in proper function from few months to a maximum of 3 years. Infection is common due to the extracorporeal nature of cable connections, drive lines, console-controllers, . . . etc. Some require adequate intrathoracic space to accommodate; (needs BSA>1.7 m2). Pulsatile devices need inflow and outflow valves. An inadequate cardiac output (COP), approximately 4-6 L/min, which does not permit physiological augmentation of COP with exercise. This method introduced abnormal metabolic and neurohumoral changes with the non-pulsatile devices due to the continuous nature of organ perfusion. All devices are pump-operated through inflow and outflow catheters. This pump operation will not solve any cardiac serious dysrhythmias; a common event in such terminal patients. Pump problems may include diaphragm rupture in 35% at 2 years.
Lastly, two common shared difficulties to both VAD's and heart transplantation have been clearer; both can help systolic dysfunction, but not diastolic dysfunction or diastolic heart failure. Both are helpless when cardiac dysrhythmias (Brady-, or Tachycardia) occur. They are unable to deliver DC shock, defibrillate or pace the slowing heart.
In developed countries, around 1-2% of adults suffer from heart failure, with an estimated annual mortality of approximately 21% in men and 17% in women. In the USA there are more than 5 million patients under treatment from congestive heart failure, with an estimated 550,000.00 new cases occur each year. Approximately one-half of the patients have moderately to severely reduced left ventricle (LV) systolic function. Approximately, these patients will need more than medical control to gain a better quality of life. The figure waiting for artificial hearts &/or cardiac transplantation is very huge.
The ICI-TAH embodiment targets patients with diseased heart muscle. Not only those with systolic failure who benefit from this embodiment, but patients with diastolic failure as well. Therefore, it targets the patient with right ventricular (RV) and/or LV Dilated-, Restrictive, and/or Hypertrophic Cardiomyopathy as well as other patients with serious pathology (e.g. native or prosthetic valvar pathology, septal defects, aneurysmal chamber dilatation, CABG-difficult patients) associated with heart failure. Patients as well with primary cardiac tumors will benefit from the embodiment. Also patients with critical intractable supraventricular or ventricular dysrhythmia, originating from whatever chamber, whether isolated or in the course of cardiomyopathy, will be candidates for the embodiment. Finally, installation includes; a stepped approach. First through surgical implantation by means of open heart surgery, with a second, more advanced, step of percutaneous catheter implantation that follows, when “ICI” is planned. A step, through transapical installation is another option.